Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery

• Sponsor: Sahmyook University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04625816
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arm: 1
• Actual Duration (Days): 21
• Patients Per Site Per Month: 79.7

Study Details

Study Description

Brief Summary

This study is an observational cross-sectional study. Post-operative patients need an immobilization period for a certain period of time after surgery. Kinetic chain changes due to immobilization can affect the symmetry of the core muscle. Therefore, in this study, core muscle asymmetry (CMA) is measured using a whole body tilt device for inpatients who have undergone arthroscopic shoulder surgery. We would like to make a clinical suggestion for post-operative rehabilitation by identifying the characteristics of CMA according to the left or right site.

Condition or Disease	Intervention/Treatment	Phase
Muscle Disorder; Postoperative Pain; Shoulder Injuries; Immobilization; Asymmetric Limb Muscle Stiffness	Device: whole body tilt device (Spine Balance 3D)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery: A STROBE-compliant Cross-sectional Study
• Actual Study Start Date: Nov 28, 2020
• Actual Primary Completion Date: Dec 12, 2020
• Actual Study Completion Date: Dec 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arthroscopic shoulder surgery patients	Device: whole body tilt device (Spine Balance 3D); The symmetry of the deep muscle was evaluated using a whole body tilt device (Spine Balance 3D, Cyber Medic Co., Ltd., Korea). Spine Balance 3D can evaluate the maintenance strength and maximum strength of the core muscles, and perform a personalized core muscle training program based on the evaluated results.

Outcome Measures

Primary Outcome Measures

1. direction core muscle ratio (DCMR) [1 Day]

   DCMR was calculated as a percentage of time located in each direction.

2. core muscle state ratio (CMSR) [1 Day]

   CMSR was calculated as a percentage of the value compared to the reference data of healthy adults.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 26 Years to 66 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• arthroscopic shoulder surgery

• limit of motion due to shoulder pain

Exclusion Criteria:

• orthopedic surgery or other medical history in the lower extremities

• neurological history or are taking related medications

• chronic headache or disease related to the inner ear

• cardiovascular disease that may affect balance ability or take related medications

• acute dizziness

• when performing other balance training

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahmyook University	Seoul		Korea, Republic of	01795

Sponsors and Collaborators

• Sahmyook University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyun-Joong Kim, Principal Investigator, Sahmyook University
• ClinicalTrials.gov Identifier: NCT04625816
• Other Study ID Numbers: 2020117HR
• First Posted: Nov 12, 2020
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscular Diseases; Shoulder Injuries

Study Results

No Results Posted as of Jan 13, 2021